D-0768-2022 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- April 20, 2022
- Initiation Date
- March 23, 2022
- Termination Date
- May 4, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1568 bottles
Product Description
Clobetasol Propionate Lotion 0.05%, Generic for Temovate, 118 mL bottle, Rx Only, Mfg: Teligent Pharma, Inc., PREFERRED Pharmaceuticals, Inc., The Physician's Solution, NDC 68788-7768-01
Reason for Recall
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc. is discontinuing its stability study program.
Distribution Pattern
IL
Code Information
Lot #: A0721O, A1421Y, A2121G, A2821D, B0421H, B0421I, B0521U, B1121G, B1921C, C0421B, C1821N, L0120F, L2320O, L3020T, Exp.: 4/30/2022; B2521A, C1121S, C2521U, D0121S, D0921B, D1421B, D2921C, E0721A, Exp.: 10/31/2022; D2221A, Exp.: 12/31/2022